2-(2-aminoethylamino)ethanol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted 1983

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-aminoethylamino)ethanol

EC Number:

203-867-5

EC Name:

2-(2-aminoethylamino)ethanol

Cas Number:

111-41-1

Molecular formula:

C4H12N2O

IUPAC Name:

2-[(2-aminoethyl)amino]ethan-1-ol

Details on test material:

- Name of test material: Aminoethylethanolamin (AEEA), test substance 89/233
- Analytical purity: 99 %
- Storage condition of test material: roóm temperature

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

microsomal enzyme systems (S-9 fraction) from Aroclor 1254-induced male Sprague-Dawley rat liver

Test concentrations with justification for top dose:

1st experiment: 0, 20, 100, 500, 2500 or 5000 µg/plate
2nd experiment: 0, 2000, 4000, 6000, 8000 µg/plate

Vehicle / solvent:

- solvent used: double distilled water

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

sterility control

Negative solvent / vehicle controls:

yes

Remarks:

solvent control

True negative controls:

no

Remarks:

with and without S-9 mix , in TA 1535, TA 1537, TA 98 and TA 100

Controls 2

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (with S-9 mix)

Remarks:

with S-9 mix , in TA 1535, TA 1537, TA 98 and TA 100

Controls 3

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

without S-9 mix , in TA 1535, TA 1537, TA 98 and TA 100

Controls 4

Positive controls:

yes

Positive control substance:

other: 4-nitro-phenylendiamine

Remarks:

without S-9 mix , in TA 1535, TA 1537, TA 98 and TA 100

Controls 5

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without S-9 mix, in TA 1535, TA 1537, TA 98 and TA 100

Details on test system and experimental conditions:

METHOD OF APPLICATION:
- standard plate and preincubation method

DURATION
- Preincubation period: 20 minutes
- Expression time (cells in growth medium): 48 h

SELECTION AGENT (mutation assays): minimal amino acid solution 0.05 mM histidine + 0.05 mM biotin

NUMBER OF PLATES:
- 3 per dose or control

DETERMINATION OF CYTOTOXICITY
- Method: colonies (his+ revertants) were counted

Evaluation criteria:

Characterization of a substance as positive requires:
- doubling of the spontaneous mutation rate
- dose-response relationship
- reproducibility of the results

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>= 2500 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

AEEA showed no mutagenic response in any strain with or without S-9 mix.
The substance was completely soluble in water. 

Cytotoxicity was only observed in the preincubation test depending on the strain at 2500 and 5000 µg/plate.

Applicant's summary and conclusion

Executive summary:

In a reverse gene mutation assay the bacteria strains TA 1535, TA 1537, TA 98 and TA 100 of S. typhimurium  were exposed to AEEA (99.0 % a.i.) at concentrations of 0, 20, 100, 500, 2000, 2500, 4000, 5000, 6000 or 8000 µg/plate (3 plates/dose) in the presence and absence of mammalian metabolic activation applying both the standard plate and the pre-incubation method (BASF AG, Department of Toxicology, 1991). AEEA was completely soluble in water and tested up to 8000 µg/plate. Cytotoxicity was only observed in the pre-incubation test depending on the strain at 2500 and 5000 µg/plate. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.

This study is classified as acceptable and satisfies the requirement of OECD Test Guideline 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.